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R&D System V&V Principal Engineer

Req #: JR - 120041 Location: Medolla, Emilia-Romagna, Italy Job Category: Research and Development Date posted: 03/21/2024

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

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R&D System V&V Principal Engineer

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary

The R&D System V&V Principal Engineer will play a key role in the confirmation by examination and provision of objective evidence that the medical equipment (i.e. Dialysis machine) is complying with regulations and specification at system level. You will collaborate with multidisciplinary teams of engineers and work in a dynamic environment.

What you'll be doing

You'll follow all the phases of Verification and Validation at system and sub-system level of a medical product, from the impact analysis, through the definition of the test activities up to the preparation of all the documentation in line with the regulatory/standard requests and the QMS.

The V&V activities include:

  • Verification of technical requirements
  • Validation of intended use and user needs
  • Safety system verification and compliance to 60601-2-16
  • Risk Control Measures verification
  • Labeling and Training material verification
  • Development of tool/test bench/test method for supporting test activities
  • Collaboration on investigation, feasibility and root cause analysis
  • Active participation in cross-functional and/or cross-sites teams
  • Support on internal and external Audit
  • Management of instruments/tools

What you'll bring

  • Master's Degree in Electronic Engineering or Biomedical Engineering
  • ISTQB certificate is preferred
  • 5+ years of experience working in R&D, in System V&V and experience with medical device products is preferred
  • Understanding of medical device product design and regulatory processes
  • Knowledge of applicable standards and regulations (FDA, ISO and IEC)
  • Deep knowledge of Design Control and of Design Of Experiments
  • Familiar with Electronic and Software instruments and tools used in V&V lab
  • Familiar with Statistical Analysis and Test Methods Validation
  • Familiar with system design, electronics, mechanical and software integration
  • Experience with LabView and Test Stand development is preferred
  • Able to communicate effectively, both verbally and in writing, within an international and multi-site environment
  • Teamworking approach, Problem-solving attitude and ability to organize and prioritize tasks

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

120041

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.

Reagan

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.

Karthik

Meet Amitha, Research Associate in India

Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter

Amitha

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Reagan

Meet Reagan, Senior Research Scientist in the United States

For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.

Karthik

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.

Amitha

Meet Amitha, Research Associate in India

Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter

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